Model Number M0063903100 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/31/2016 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used during a ureteroscopy (urs) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the device broke inside the patient.The detached part was successfully retrieved using endoscopic forceps.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be well.
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Manufacturer Narrative
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A visual analysis of the returned device revealed that the distal stop and distal end of the coil is detached and was not returned.Additionally, a burn mark was noted on the blue green shrink indicating that the device was scorched.The device shows evidence of scorching, which is most likely caused by the lithotripsy procedure.Therefore, the root cause of this complaint is caused by other device.The device history record (dhr) review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.A labeling review was performed and no anomaly was found.
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Event Description
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It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used during a ureteroscopy (urs) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the device broke inside the patient.The detached part was successfully retrieved using endoscopic forceps.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be well.
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Search Alerts/Recalls
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